Medical Device Validation Document Resources

This blog provides a list of medical device validation resources and explains how to create your resource list.

The first step to understanding how to conduct successful validations are always to read and re-read the requirements of the documents below:

• 21 CFR 820.30(g)
• 21 CFR 820.75
• ISO 13485, Clause 7.3
• ISO 13485, Clause 7.5.2

Unfortunately, we sometimes need to consult a reference guide that explains aspects of the requirements.

Max Sherman (http://bit.ly/MaxSherman) is finishing a new handbook on design and process validation that will be published through RAPS. The following is a list of resources for the process and design validation that I am submitting for publication in the book. Many of these resources are free, and these are the resources I use to learn and teach principles of validation.

1. GHTF/SG3/N99-10:2004 – Process Validation Guidance (http://bit.ly/N99-10)
2. ISO 14969 – ISO Guidance document for ISO 13485 (http://bit.ly/iso14969)
3. 13485 Plus – CSA Guidance document for ISO 13485 (http://bit.ly/13485Plus)
4. AAMI The Quality System Compendium: Bundled Set of Textbook & CD (http://bit.ly/AAMI-Store)
5. The preamble to the QSR (http://bit.ly/QSR-preamble)
6. ICH Q2: Validation of Analytical Procedures: Text and Methodology (http://bit.ly/Q2-Analytical-Validation)
7. FDA Guidance for Part 11: Electronic Records (http://bit.ly/Part11Guidance)
8. FDA Guidance for Software Validation (http://bit.ly/FDA-Software-Validation)
9. FAQs about Implementation of IEC 62304:2006 (http://bit.ly/Team-NB-IEC62304)

In addition to these resources, you may also need additional resources for design validation. Here are some examples of design validation resources I use in my design controls training “tool kit:”

1. http://bit.ly/do-it-by-design
2. http://bit.ly/DesignControlGuidance

As regulatory affairs professional, it is critical to maintain a list of the most current standards and an organized list of links to those standards. I used to keep a list of favorites in my web browser for this purpose, but my database now exceeds the utility of “favorites.” Now, I use my webpage for this purpose. You can do this yourself by creating a free WordPress blog, and having one of the webpages to the blog be specifically to maintain a list of applicable Standards. Here’s a link to my webpage that I share: http://bit.ly/RA-Resources